Events

Rappel de Device Recall Spectre Wireless Footswitch/Handswitch system

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Trans American Medical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0532-2014
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • Date de publication de l'événement
    2014-01-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121427
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, X-Ray, Mobile - Product Code IZL
  • Cause
    Transamerican medical imaging is recalling certain lots of tmi spectre wireless footswitch/hand switch for ge oec 9800/9900 and philips fds and fdb cath labs due to potential safety issue related to the use of this product producing uncommanded x-ray.
  • Action
    TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.

Device

Device Recall Spectre Wireless Footswitch/Handswitch system
  • Modèle / numéro de série
    Serial numbers NS 10324 through NS 10392
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution: including states of: WA and UT.
  • Description du dispositif
    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. || The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
  • Manufacturer
    Trans American Medical, Inc.

Manufacturer

Trans American Medical, Inc.
  • Adresse du fabricant
    Trans American Medical, Inc., 965 W 325 N, Lindon UT 84042
  • Source
    USFDA